MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER

Model Number	73022L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the several catheters had an issue.It was stated that the catheter had a hole in it.Per follow up made on 31mar2021, picture sample was provided and it showed the hole in catheter and unable to saw the hole with naked eye.Per additional information received on 28may2021, customer had same hole issue with the same lot number.Another catheter was used to finish the case.Also stated that 5 more catheters (unused) were affected from that lot.
Event or Problem Description
It was reported that the several catheters had an issue.It was stated that the catheter had a hole in it.Per follow up made on 31mar2021, picture sample was provided, and it showed the hole in catheter and unable to saw the hole with naked eye.Per additional information received on 28may2021, customer had same hole issue with the same lot number.Another catheter was used to finish the case.It was also stated that 5 more catheters (unused) were affected from that lot.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "damage core pin or insert / hit insert against the mold or the table".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use".H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12040992
• Report Number: 1018233-2021-03679
• Device Sequence Number: 3465418
• Product Code: EZL
• UDI-Device Identifier: 00801741034329
• UDI-Public: (01)00801741034329
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 73022L
• Device Catalogue Number: 73022L
• Device Lot Number: NGET2555
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other